Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier function of a standard examination glove, with no mention of AI or ML.

Therapeutic

No
The device is a medical glove intended for preventing contamination, not for treating a disease or condition.

Diagnostic

No

This device is a protective glove intended to prevent contamination, not to diagnose a medical condition. Its function is barrier protection, as indicated by "worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a Class I latex patient examination glove, which is a physical hardware product, not software. The performance studies also focus on physical properties of the glove.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The description clearly states the device is a "chemotherapy examination glove" worn on the hand or finger to prevent contamination. Its purpose is a physical barrier, not to analyze biological samples.
Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic testing. The performance studies focus on the physical properties and barrier function of the glove.

Therefore, based on the provided information, this device is a medical glove intended for protection and contamination prevention, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.

Product codes (comma separated list FDA assigned to the subject device)

LYY

Device Description

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel and similar personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
Key Results:

Watertight: Pass based on AQL of 1.5 (ASTM D 3578-91 requirement: S-4, AQL 4.0)
Length (mm):
XS: 292
S: 304 (ASTM D 3578-91 requirement: min 230)
M: 308 (ASTM D 3578-91 requirement: min 230)
L: 308 (ASTM D 3578-91 requirement: min 230)
XL: -
Palm width (mm):
XS: 83
S: 95 (ASTM D 3578-91 requirement: 80 +/- 10)
M: 95 (ASTM D 3578-91 requirement: 95 +/- 10)
L: 106 (ASTM D 3578-91 requirement: 111 +/- 10)
XL: -
Thickness (mm):
Finger: 0.46 (ASTM D 3578-91 requirement: min 0.08)
Palm: 0.27 (ASTM D 3578-91 requirement: min 0.08)
Physical Properties:
Before Ageing:
Tensile Strength (MPa): 30.78 (ASTM D 3578-91 requirement: min 21)
Ultimate Elongation (%): 839 (ASTM D 3578-91 requirement: min 700)
After Ageing:
Tensile Strength (MPa): 27.41 (ASTM D 3578-91 requirement: min 16)
Ultimate Elongation (%): 845 (ASTM D 3578-91 requirement: min 500)
Powder Content: below 2 mg / glove
Moisture Content: max 0.8% / glove
Protein Content: below 50 microgram / gram

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram.
This glove exceed the ASTM D 3578 91 requirements, meet pinhole FDA requirements, and below 50 microgram / gram protein content labeling claim.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" for detailed metrics (Watertightness AQL, Length, Palm width, Thickness, Tensile Strength, Ultimate Elongation, Powder Content, Moisture Content, Protein Content). Specific metrics like Sensitivity, Specificity, PPV, NPV are not applicable or provided for this device type.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

Image /page/0/Picture/1 description: The image shows a logo with the letters WRP in bold, black font. The letters are arranged horizontally, with the W on the left, R in the middle, and P on the right. The logo is enclosed in a black, rounded rectangular border. The logo appears to be a trademark or brand identifier.

972615

WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)

l.ot 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia nrketing / QA Tel: (603) 846-1486 / 1867 Fax: (603) 846-1485 / 1557 Operations Tel: (603) 846-1495 / 1496 Fax: (603) 846-1488 / 1608

CONTACT PERSON : MR. Y. W. CHOW

510 (K) SUMMARY

Trade Name : CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

1. Common Name : Examination Gloves
1. Classification Name : Patient Examination Glove

4. Substantial Equivalence :

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

5. Description of device :

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

6. Intended use of device :

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Page 1 of 3

Image /page/0/Picture/17 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the circle. Below the logo, there is some text that is not clearly visible due to the image quality.

Image /page/0/Picture/18 description: The image is a black and white circular logo. The logo contains the words "REGISTERED FIRM" around the outside of the circle. Inside the circle is a downward-pointing triangle above a heart shape. Above the circle is a symbol that looks like a crown.

Image /page/0/Picture/19 description: The image shows a logo with the word "REGISTERED" in a white oval shape, placed on top of a black diamond shape. Below the diamond, there is text that reads "MS ISO 9002 : 1994". The logo appears to be a certification mark, possibly indicating compliance with the MS ISO 9002 standard from 1994.

Image /page/0/Picture/20 description: The image shows the CE marking, a symbol used to indicate conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The marking consists of the letters "CE" in a specific font and layout. Below the CE marking, the text "COUNCIL DIRECTIVE 93/42/EEC" is visible, indicating the specific directive related to medical devices.

EN 16001 (1002) AND EN 20001 (1007)

1

7. Summary of Performance data :

:

92615

| TEST | ASTM D 3578-91 | CHEMO PLUS Powder Free
Blue Latex Examination
Gloves (Protein Content
Labeling) |
|---------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | | |
| Size
XS
S
M
L
XL | -
min 230
min 230
min 230

```
         | -
```

292
304
308

| -
83
95
106

Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.

2

K972615

8. Substantial Equivalence based on assessment of Non-Clinical performance data

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.

Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram.

9. Conclusion

This glove exceed the ASTM D 3578 91 requirements, meet pinhole FDA requirements, and below 50 microgram / gram protein content labeling claim.

Date Summary Prepared : June 17, 1997

Page 3 of 3

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 26 1999

Mr. Chow Yue Wah Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

K972615 Re : Chemo Plus Powder-Free Blue Latex Trade Name: Examination Gloves (Protein Labeling Claim 50 Micrograms or Less) Regulatory Class: I Product Code: LYY November 10, 1998 Dated: November 17, 1998 Received:

Dear Mr. Chow Yue Wah:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

4

Page 2 - Mr. Chow Yue Wah

through 542 of the Act for devices under the Electronic chrough 342 or eno notrol provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acinding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmama/n.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

510(k) Number (if known) : _ K972615

Device Name : CHEMO PLUS POWDER FREE BLUE LATEX EAMINATION GLOVES (PROTEIN CONTENT LABELING) 50 MICROGRAMS OR LESS

Indications For Use :

1. The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
  Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

:

Over-The-Counter Use OR

Qlin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infect 510(k) Number